[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603386":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":41,"locations":50,"responsibleParty":69,"collaborators":23,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":23,"enrollmentInfo":83,"targetDuration":23,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":52,"whyStopped":23,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Heidelberg University","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital exercise program with personal coaching (Intervention Group 1)","EXPERIMENTAL","Participants receive a tablet with the pre-installed training app KOKU, which delivers a 12-week standardized digital home-based strength and balance program. Participants are introduced to KOKU during an initial home visit and are encouraged to complete the program independently over the subsequent 12 weeks. In addition, they receive three individualized coaching sessions via video calls on the tablet during this period. To support self-monitoring and provide feedback on PA behavior - integrated into the BCTs used in the personal coaching - participants also receive a low-cost, easy-to-use wrist-worn activity tracker along with instructions on its use during the initial home visit.",[13,14],"Behavioral: Digital exercise program","Behavioral: Personal coaching for physical activity promotion",{"label":16,"type":10,"description":17,"interventionNames":18},"Digital exercise program without personal coaching (Intervention Group 2)","Participants receive a tablet with the pre-installed training app KOKU, which delivers a 12-week standardized digital home-based strength and balance program. Participants are introduced to KOKU during an initial home visit and are encouraged to complete the program independently over the subsequent 12 weeks. No personal coaching is provided.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Usual care (Control Group)","NO_INTERVENTION","Participants receive a tablet without access to the KOKU app and do not receive any personal coaching sessions.",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"BEHAVIORAL","Digital exercise program","KOKU is a digital adaptation of the evidence based Otago Exercise Program and Falls Management Exercise program, both designed to improve strength, balance, and reduce fall risk in older adults. KOKU includes 26 balance and strength exercises of varying difficulty. Each exercise is accompanied by written and audio instructions for safe performance and is demonstrated by a virtual trainer. Training sessions consist of three exercises suggested by the KOKU app, which participants are encouraged to perform for as many repetitions as possible until fatigue. Progression is guided by the participant's subjective assessment of effort and difficulty. Participants may choose to perform any exercise at any time, regardless of the app-suggested sequence. The KOKU app also provides reminders to exercise if no activity is detected for two days.",[9,16],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"Personal coaching for physical activity promotion","Personal coaching consists of three video calls conducted via the study tablet by staff trained in BCTs and motivational communication skills. Participants receive a low cost, wrist worn activity tracker during the initial home visit to support self-monitoring and provide feedback on PA behavior. The first virtual coaching session (week 2) focuses on goal setting and action planning, the second session (week 3) addresses identification and management of barriers, and the third session (week 12) serves as a booster to review and adjust activity goals for the post intervention period.",[9],[35,39],{"name":36,"affiliation":37,"role":38},"Tobias Reiner, PhD, MD","Department of Orthopaedics, Heidelberg University Hospital","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":38},"Christian Werner, PhD",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},"Tobias Eckert, PhD","CONTACT","+49 (0)6221 319 1562","tobias.eckert@med.uni-heidelberg.de",{"name":40,"role":44,"phone":48,"phoneExt":23,"email":49},"+49 (0)6221 319 1759","christian.werner@med.uni-heidelberg.de",[51],{"facility":37,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Heidelberg","Baden-Wurttemberg","69118","Germany","DE",{"type":59,"coordinates":60},"Point",[61,62],8.69079,49.40768,{"lat":62,"lon":61},[65],{"name":66,"role":44,"phone":67,"phoneExt":23,"email":68},"Tobias Reiner, Priv.-Doz. Dr. med.","+49 (0)6221 25000","tobias.reiner@med.uni-heidelberg.de",{"type":38,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":72,"oldNameTitle":23,"oldOrganization":23},"Tobias Reiner","Priv.-Doz. Dr. med.","University Hospital Heidelberg","100603386","digital-home-based-physical-activity-promotion-for-older-adults-after-total-hip-arthroplasty-100603386",false,"NCT07135843","Digital Home-Based Physical Activity Promotion for Older Adults After Total Hip Arthroplasty","iPATH - Digital Home-Based Training for Physical Activity Promotion in Older Adults After Total Hip Arthroplasty: A Randomized Controlled Trial","iPATH","Inclusion Criteria:\n\n* Age ≥65 years\n* Coxarthrosis with indication for total hip arthroplasty\n* Residence within a radius of ≤50 km from Heidelberg\n* Ability to walk ≥10 m (with\u002Fwithout walking aid)\n* Access to the internet (Wi-Fi) at home\n* Written informed consent\n\nExclusion Criteria:\n\n* Insufficient German language skills\n* Insufficient hearing to communicate via (video) telephone\n* Insufficient vision to recognize study materials\n* Contralateral coxarthrosis with indication for total hip arthroplasty\n* Severe medical condition illnesses that compromise physical fitness (heart failure classified as New York Heart Association \\[NYHA\\] class ≥3, heart valve defects associated with syncope, cardiac arrhythmia with dizziness, chronic obstructive pulmonary disease \\[COPD\\] with oxygen therapy, cancer with chemotherapy and\u002For radiation, Parkinson's disease with rollator use \\[Hoehn \\& Yahr stage ≥4\\])\n* Living in a nursing home\n* Planned major medical procedure within the next 6 months with inpatient hospital stay (e.g., further surgery)\n* Simultaneous participation in another competing study\n* Cognitive impairment (6-item Cognitive Impairment Test \\[6CIT\\] score \\>7 points)","ALL","65 Years",{"count":84,"type":85},213,"ESTIMATED","INTERVENTIONAL",[88],"NA","The goal of this clinical trial is to evaluate the efficacy of a 12-week digital home-based intervention program, consisting of a tablet-based exercise program with or without personal coaching, to promote physical activity (PA) in older adults after total hip arthroplasty (THA). The main question it aims to answer is:\n\n• Does the combination of the digital exercise program and personal coaching lead to higher PA six months after THA compared to usual care among older adults?\n\nSecondary questions are:\n\n* Does the digital exercise program alone lead to higher PA compared to usual care?\n* Does the digital exercise program combined with personal coaching lead to higher PA compared to the exercise program alone?\n\nParticipants' PA will be objectively measured with a body-fixed sensor at 1 week before THA (T1), 6 weeks after THA (T2), and 6 months (i.e. after THA (T3). After the postoperative assessment at T2, participants will be randomly assigned to one of three groups:\n\n* 12-week tablet-based exercise program at home with virtual personal coaching for physical activity promotion\n* 12-week tablet-based exercise program at home\n* Usual care (control group, no additional intervention)",[91,92],"Total Hip Arthroplasty (THA)","Older Adults (65 Years and Older)",[94,95,96,97,98,99,100,101,102,103],"Total Hip Arthroplasty","Physical Activity","Older Adults","Digital Intervention","Physical Exercise","Coaching","Patient Education","Postoperative Care","Ambulatory Monitoring","Behavior Change","2025-08-29",{"date":106,"type":107},"2025-09-02","ACTUAL",{"date":109,"type":85},"2025-09",{"date":111,"type":85},"2028-01",{"name":5,"class":6},1]